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Compugen Announces First Patient Dosed in COM701 Global Platform Trial in Platinum Sensitive Ovarian Cancer

On July 21, 2025 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in predictive computational target discovery powered by AI/ML, reported that the first patient was dosed in the global randomized sub-trial 1 of adaptive platform trial, MAIA-ovarian (which stands for MAintenance Immunotherapy with an Anti-PVRIG antibody), evaluating maintenance therapy with single agent COM701, a potential first-in-class anti-PVRIG antibody in patients with relapsed platinum sensitive ovarian cancer (Press release, Compugen, JUL 21, 2025, View Source [SID1234654451]).

"We are delighted to advance the development of COM701 as a maintenance therapy for patients with relapsed platinum sensitive ovarian cancer, potentially addressing a significant unmet medical need," said Anat Cohen-Dayag, Ph.D., President, and CEO of Compugen. "This global trial is underpinned by a strong biological rationale, with high PVRIG pathway expression levels observed in ovarian cancer. In addition, clinical data showed that COM701 in triple combination with PD-1 and TIGIT blockade achieved durable responses and was well tolerated in patients with heavily pre-treated platinum resistant ovarian cancer typically not responding to immunotherapy. A response of greater than 18 months was also achieved in a patient treated with COM701 as a single agent."

Dr. Cohen-Dayag continued, "Based on historical data, we anticipate the benchmark for progression-free survival to be around six months and consider a three-month improvement over placebo to be clinically meaningful for these patients. An interim analysis of sub-trial 1 of MAIA-ovarian is planned to take place in the second half of 2026. We believe positive data could inform a registration path for COM701 monotherapy and an opportunity to combine COM701 with other agents, broadening COM701’s opportunities within the ovarian cancer population."

Ruth Peres, M.D., Ph.D., Medical Oncologist in the Division of Oncology, Head of Women’s Cancers Research Lab and Head of Phase 1 Clinical Trials in the Clinical Research Institute at Rambam Healthcare Campus, Haifa, Israel, added, "There is a need for drugs that provide durable responses and a favorable safety profile as maintenance therapy in patients with platinum sensitive ovarian cancer who respond to chemotherapy, but who are not candidates for bevacizumab or PARP inhibitors. We are delighted to be the first site to dose a patient in this sub-trial designed to evaluate if COM701 as a single agent can delay disease progression in these patients."

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About MAIA-ovarian

(MAintenance Immunotherapy with an Anti-PVRIG antibody: COM701, as maintenance monotherapy or combination therapy in patients with relapsed platinum sensitive ovarian cancer.)

MAIA-ovarian is a global adaptive platform trial to evaluate the safety and efficacy of COM701 as maintenance monotherapy or combination therapy in patients with relapsed platinum sensitive ovarian cancer. The purpose of sub-trial 1 is to assess if COM701 delays the progression of ovarian cancer in patients with relapsed platinum sensitive ovarian cancer and further assess its safety profile in this disease setting. The adaptive-platform design enables additional sub-trials. Sub-trial 1 is a double-blind, randomized placebo-controlled trial in which 60 patients will be randomized in a 2:1 ratio to COM701 or placebo. Subsequent sub-trials may evaluate COM701 in combination with other anticancer drugs. For more information about this trial, visit clinicaltrials.gov, NCT06888921.

ArriVent’s Topline Pivotal Phase 3 FURVENT Data for Firmonertinib in First-Line NSCLC EGFR Exon20 Insertion Mutations is Projected to be Early 2026

On July 21, 2025 ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, reported that topline firmonertinib monotherapy data from the global pivotal FURVENT Phase 3 (NCT05607550) study in first-line EGFR exon20 insertion mutant non-small cell lung cancer (NSCLC) is projected to be in early 2026 (Press release, ArriVent Biopharma, JUL 21, 2025, View Source [SID1234654448]). The primary endpoint will assess progression free survival (PFS) by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. In the first quarter of 2025, the study completed enrollment across global sites.

About FURVENT

FURVENT is a global, pivotal 3 arm Phase 3 clinical trial of firmonertinib in first-line non-squamous locally advanced or metastatic NSCLC patients with exon 20 insertion mutations being conducted jointly with our partner Allist. The FURVENT clinical trial is designed to assess the safety and efficacy of firmonertinib administered at either 160 mg or 240 mg, once-daily with each dose being compared to platinum-based chemotherapy with pemetrexed, the current first-line standard of care. The primary endpoint of this study is PFS by BICR per RECIST 1.1. Seconday endpoints in patients with brain metastases at baseline include brain-specific CNS overall response rate (CNS-ORR) and CNS-PFS by modified RECIST (mRECIST). The study enrolled 398 patients globally, including from sites in the United States, Europe and certain Asian countries including Japan and China.

About Firmonertinib

Firmonertinib is an oral, highly brain-penetrant, and broadly active mutation-selective epidermal growth factor receptor (EGFR) inhibitor active against both classical and uncommon EGFR mutations, including PACC and exon 20 insertion mutations. In March 2021, firmonertinib was approved in China for first-line advanced non-small-cell lung cancer (NSCLC) with EGFR exon 19 deletion or L858R mutations and for patients with previously treated locally advanced or metastatic NSCLC with EGFR T790M mutation, otherwise known as EGFR classical mutations.

Firmonertinib was granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation for the treatment of patients with previously untreated locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations. Firmonertinib was also granted U.S. FDA Orphan Drug Designation for the treatment of NSCLC with EGFR mutations or human epidermal growth factor receptor 2 (HER2) mutations or HER4 mutations.

Firmonertinib is currently being studied in a global Phase 3 trial for first-line NSCLC patients with EGFR exon 20 insertion mutations (FURVENT; NCT05607550) and in a global Phase 3 study in first line NSCLC patients with EGFR PACC mutations (ALPACCA). In addition, firmonertinib is also being studied in a clinical combination study targeting advanced or metastatic NSCLC patients with EGFR classical mutations, in partnership with Beijing InnoCare Pharma Tech Co., Ltd.

About EGFR mutant NSCLC

Globally, lung cancer is the leading cause of cancer-related deaths among men and women. NSCLC is the predominant subtype of lung cancer, accounting for approximately 85% of all cases. Mutational activation of the EGFR is a frequent and early event in the development of NSCLC. EGFR mutations are divided into classical and uncommon. EGFR exon 20 insertion mutations are a group of uncommon EGFR mutations and constitute approximately 9% of all EGFR mutations. PACC mutations are another group of uncommon EGFR mutations and represent approximately 12% of all EGFR mutations. Patients with NSCLC whose tumors harbor uncommon EGFR mutations have significantly lower life expectancy with available therapies and represent an area of unmet medical need.

Amneal Reports Certain Preliminary Second Quarter 2025 Financial Results

On July 21, 2025 Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) ("Amneal" or the "Company") reported certain unaudited preliminary financial results for the second quarter ended June 30, 2025 (Press release, Amneal Pharmaceuticals, JUL 21, 2025, View Source [SID1234654447]). The Company plans to report actual second quarter 2025 financial results on August 5, 2025.

Unaudited Preliminary Financial Results for the Second Quarter Ended June 30, 2025

Net revenue of $720 million to $730 million, an increase of approximately 3% versus the same period in 2024
Income before income taxes of $45 million to $56 million, versus $20 million in the same period in 2024
Adjusted EBITDA of $180 million to $185 million, an increase of approximately 13% versus the same period in 2024
Gross leverage decreased to 3.8x as of June 30, 2025, compared to 4.1x as of December 31, 2024, and net leverage decreased to 3.7x as of June 30, 2025, compared to 3.9x as of December 31, 2024, due to higher profitability and continued debt reduction
"Amneal continued to deliver robust growth and further deleveraging underscoring the power of our diversified pharmaceutical business. Based on our performance year-to-date and multiple growth drivers, we expect to meet or exceed our full year 2025 guidance. This quarter also marked the U.S. FDA approval of Brekiya autoinjector for the acute treatment of migraine and cluster headache in adults, as well as strong commercial uptake of CREXONT. Finally, we look forward to an expected BLA submission for a proposed biosimilar to XOLAIR in the fourth quarter of 2025. With a strong foundation, a relentless execution focus, and a deep pipeline, Amneal is well-positioned to deliver long-term growth," said Chirag and Chintu Patel, Co-Chief Executive Officers and Co-Founders.

Amneal’s preliminary financial results are based on the most recent information available to the Company’s management. Such preliminary financial results are forward-looking statements. Actual results may differ from these preliminary financial results due to the completion of the Company’s financial close procedures, final accounting adjustments and other developments that may arise between the date of this Current Report on Form 8-K and the time that financial results for the second quarter of 2025 are finalized, and such differences may be material. The preliminary financial results for the second quarter of 2025 are not necessarily indicative of the results to be achieved in any future period. The Company presents GAAP and adjusted (non-GAAP) quarterly results. Please refer to the "Non-GAAP Financial Measures" section and the accompanying GAAP to non-GAAP reconciliation tables for more information.

Orion Group Half-Year Financial Report January–June 2025

On July 18, 2025 Orion reported Half-Year Financial Report January to June 2025.

(Presentation, Orion, JUL 18, 2025, View Source [SID1234661693])

MEI Pharma Announces $100,000,000 Private Placement to Initiate Litecoin Treasury Strategy, Becoming First and Only Publicly Traded LTC Holder on a National Exchange

On July 18, 2025 MEI Pharma, Inc. (Nasdaq: MEIP) (the "Company" or "MEI") reported that it has entered into securities purchase agreements for a private investment in public equity (PIPE) for the purchase and sale of 29,239,767 shares of common stock (or pre-funded warrants in lieu thereof) at a price of $3.42 per share, for expected aggregate gross proceeds of approximately $100 million, before deducting placement agent fees and other estimated offering expenses (Press release, MEI Pharma, JUL 18, 2025, View Source [SID1234654468]). In connection with the closing of the transaction, MEI will appoint Charlie Lee to its Board of Directors (at which time current member Taheer Datoo will resign) and GSR as its digital asset and treasury management advisor to oversee the implementation of its Litecoin Treasury Strategy.

Charlie Lee and GSR acted as lead investors, alongside participation from the Litecoin Foundation as well as prominent crypto venture capital firms and infrastructure providers including MOZAYYX, ParaFi, Hivemind, Primitive, RLH Capital, Delta Blockchain & CoinFund, among others.

This transaction marks a significant milestone in MEI’s long-term strategic plan and establishes MEI as the first and only publicly traded company to adopt Litecoin as a treasury reserve asset. Litecoin (LTC) is a leading peer-to-peer cryptocurrency that was created by Charlie Lee in October 2011. It is often referred to as the "silver to Bitcoin’s gold" due to its similarities to Bitcoin. As one of the longest-running blockchains with 100% uptime since its inception, Litecoin has demonstrated a proven track record of growth and reliability with significant enterprise-grade use cases. By integrating Litecoin into its treasury operations, MEI gains access to a decentralized monetary asset that complements its cash management framework.

"Litecoin was designed to be fast, secure, and decentralized – and it’s exciting to see those principles now being embraced by a public company like MEI," said Charlie Lee, Creator of Litecoin. "This milestone not only reflects growing institutional confidence in LTC but also sets the stage for broader adoption in traditional capital markets."

"We’re thrilled to partner with MEI in building a thoughtful LTC-focused treasury strategy," said Josh Riezman, US Chief Strategy Officer of GSR. "Our goal is to help institutions unlock the long-term potential of digital assets while managing risk and maintaining flexibility. This treasury strategy is centered around a completely fair and fully decentralized digital asset with a nearly unparalleled track record as a store of value and means of payment.

"MEI is pleased to pioneer this innovative public company treasury strategy with GSR and Charlie Lee, the first to our knowledge in the biotech sector," said Frederick W. Driscoll, Chairman of the Board of MEI.

The closing of the PIPE is expected to occur on or about July 22, 2025, subject to the satisfaction of customary closing conditions. The Company intends to use the funds to acquire the native cryptocurrency of the Litecoin blockchain commonly referred to as "LTC", which will serve as the Company’s primary treasury reserve asset.

Titan Partners Group, a division of American Capital Partners, is acting as the sole placement agent in connection with the PIPE.

The offer and sale of the foregoing securities is being made in a private placement in reliance on an exemption from the registration requirement of the Securities Act of 1933, as amended (the "Securities Act"), pursuant to Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder, and applicable state securities laws. Accordingly, the securities offered in the private placement may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirement of the Securities Act and such applicable state securities laws. Concurrently with the execution of the securities purchase agreements, the Company and the investors entered into a registration rights agreement pursuant to which the Company has agreed to file a registration statement with the Securities and Exchange Commission (the "SEC") registering the resale of the shares of common stock. Any offering of the Company’s Common Stock under the resale registration statement will only be made by means of a prospectus.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

The private placement is being conducted in accordance with applicable Nasdaq rules and was priced to satisfy the "Minimum Price" requirement (as defined in the Nasdaq rules).